Evaluating Biotech Stock Momentum: Why ImmunityBio Remains a Buy Despite Market Volatility

In the volatile landscape of biotech investing, ImmunityBio (IBRX) stands out as a compelling long-term opportunity, driven by its innovative immunotherapy platform and a clinical pipeline that consistently delivers breakthrough results. Despite market fluctuations, the company's strategic focus on immune system restoration and its robust regulatory progress position it as a resilient contender in oncology. This analysis underscores why ImmunityBio remains a “buy,” even as broader market uncertainties persist.

The Foundation of Innovation: ANKTIVA's Clinical Breakthroughs

At the core of ImmunityBio's value proposition is ANKTIVA® (N-803), a first-in-class IL-15 agonist that has redefined the treatment paradigm for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). In April 2024, the FDA approved ANKTIVA for this indication, following a 62% complete response rate in 77 evaluable patients, with some responses lasting over 47 monthsImmunityBio Announces FDA Approval of ANKTIVA First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer^[4]. This milestone not only validated the therapy's efficacy but also established ImmunityBio as a leader in bladder cancer immunotherapy.

Beyond bladder cancer, ANKTIVA has demonstrated versatility in addressing lymphopenia—a life-threatening immune deficiency caused by chemotherapy, radiation, and immunotherapy. In June 2025, the FDA granted expanded access authorization for ANKTIVA to treat lymphopenia in refractory solid tumor patientsImmunityBio Receives FDA Expanded Access Authorization for Landmark Treatment of Lymphopenia With ANKTIVA®, the Cancer BioShield™ Platform, in Patients With Solid Tumors^[5]. Clinical data from the QUILT-3.055 trial revealed that 80% of advanced NSCLC patients achieved an absolute lymphocyte count above 1,000 cells/µL, with a median overall survival of 21.1 months, far exceeding historical benchmarksImmunityBio Provides Regulatory Update on Anticipated FDA Submissions in 2025 Following Meeting with the Agency^[2]. These results highlight ANKTIVA's potential to extend survival in treatment-resistant cancers, a critical differentiator in an era where conventional therapies often fail.

Strategic Partnerships and Pipeline Expansion

ImmunityBio's clinical pipeline is not only deep but also strategically aligned with unmet medical needs. The company's collaboration with BeiGene on a Phase 3 trial combining ANKTIVA with a PD-1 checkpoint inhibitor for non-small cell lung cancer (NSCLC) underscores its commitment to expanding therapeutic applicationsLatest News in Targeted Cell Therapies for Cancer ... - ImmunityBio^[6]. Similarly, its partnership with the Serum Institute of India to secure a global BCG supply addresses critical shortages in bladder cancer treatment, ensuring scalability for ANKTIVA's broader useLatest News in Targeted Cell Therapies for Cancer ... - ImmunityBio^[6].

The pipeline's diversity is further evident in trials targeting glioblastoma, pancreatic cancer, and HPV-related malignancies. Notably, a combination of ANKTIVA, NK cell therapy, and the Optune Gio® device achieved 100% disease control in five recurrent glioblastoma patients, with two achieving near-complete responsesImmunityBio Receives FDA Expanded Access Authorization for Landmark Treatment of Lymphopenia With ANKTIVA®, the Cancer BioShield™ Platform, in Patients With Solid Tumors^[5]. Such data reinforces the company's “triangle offense” strategy—leveraging in-vivo immune stimulation, ex-vivo cytotoxicity, and memory-enhancing therapies—to tackle complex tumors.

Regulatory Momentum and Financial Resilience

Regulatory validation has been a cornerstone of ImmunityBio's growth. ANKTIVA received Regenerative Medicine Advanced Therapy (RMAT) designation for reversing lymphopenia in advanced pancreatic cancer patients, accelerating its path to commercializationImmunityBio Announces FDA Approval of ANKTIVA First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer^[4]. Additionally, the company plans to submit a Biologics License Application (BLA) in 2025 for NSCLC treatment, further solidifying its market positionImmunityBio Provides Regulatory Update on Anticipated FDA Submissions in 2025 Following Meeting with the Agency^[2].

Financially, ImmunityBio has demonstrated resilience. A 60% revenue increase in Q2 2025Latest News in Targeted Cell Therapies for Cancer ... - ImmunityBio^[6] reflects strong commercial adoption of ANKTIVA, supported by coverage from over a dozen insurance plans post-approvalLatest News in Targeted Cell Therapies for Cancer ... - ImmunityBio^[6]. This financial performance, coupled with a pipeline of 18 Phase 2/3 trials across 13 indicationsMedical Studies & Immunotherapies - Advanced Clinical Research^[3], provides a durable foundation for long-term value creation.

Market Volatility and the “Buy” Case

While biotech stocks face inherent volatility, ImmunityBio's fundamentals act as a buffer. H.C. Wainwright, a prominent investment firm, has highlighted the company's clinical progress and strategic partnerships as key drivers of future upsideImmunityBio’s ANKTIVA® Reverses Lymphopenia and Extends Overall Survival in Patients With Advanced Non-Small Cell Lung Cancer Resistant to Checkpoint Therapy^[1]. The firm's “buy” rating, though not explicitly detailed in recent reports, aligns with the broader market sentiment that views ImmunityBio's immune-boosting platform as a transformative force in oncology.

The analogy to standard libraries (like .h files) is apt: just as foundational code enables complex systems, ImmunityBio's therapies—particularly ANKTIVA—provide a platform for addressing multiple diseases. This modular approach reduces development risks and accelerates innovation, making the company a high-conviction play for investors seeking long-term growth.

Conclusion

ImmunityBio's combination of clinical innovation, regulatory momentum, and strategic partnerships positions it as a standout in the biotech sector. While market volatility remains a concern, the company's focus on immune system restoration—backed by landmark approvals and robust trial data—provides a compelling rationale for a “buy” rating. For investors willing to look beyond short-term fluctuations, ImmunityBio represents a high-impact opportunity in the evolving landscape of cancer immunotherapy.